BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT

    MDR report key: 12312194 · Received August 12, 2021

    Report

    Report Number
    12312194
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 10, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN ARTERIOGRAM OF THE RIGHT LOWER EXTREMITY IN SPECIAL PROCEDURES BY DOCTOR. DURING THE PROCEDURE, TWO (2) BARD LIFESTENTS SIZES 5MM X 120MM WERE DEPLOYED INTO THE RIGHT FEMORAL ARTERY. UPON RETRIEVING THE STENT CATHETER FROM THE VESSEL, THE DISTAL END DISLODGED INTO THE RIGHT LOWER EXTREMITY VESSEL (ARTERY). MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE DISLODGED CATHETER BY DOCTORS PRESENT. BOTH WERE UNSUCCESSFUL. A CONSULT WAS IMMEDIATELY CALLED TO CARDIOVASCULAR SERVICES. AT CLOSE OF CASE, PATIENT WAS HEMODYNAMICALLY STABLE. PATIENT RECOVERED IN CVRU (CARDIOVASCULAR RECOVERY UNIT) HOLDING AREA FOR 2 HOURS BEFORE RETURNING TO ORIGINAL FLOOR. BARD REPRESENTATIVE WAS NOTIFIED OF INCIDENT. REFERENCE NUMBER WERE (B)(4) FOR BOTH STENTS AND LOT NUMBERS WERE ANEU0465 (EXP DATE 07/03/2023) AND ANEY3110 (EXP DATE 11/20/2023). PRODUCT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208805 LIFESTENT STENT, SUPERFICIAL FEMORAL ARTERY NIP BARD PERIPHERAL VASCULAR, INC. 5F051203CS ANEU0465 AND ANEY3110

    Patients

    Seq Age Sex Outcome Treatment
    1